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Insulin resistance can be assessed by the euglycaemic clamp technique. To date, this is the golden standard, but it is not suited for clinical practice. A 13C glucose breath test will be tested as a valid alternative. The curve of the exhaled 13C CO2 as a function of glucose metabolism can be correlated to the curve of the glucose disposal rate obtained via the clamp technique.
The hyperinsulinemic-euglycemic clamp technique is the golden standard to assess insulin resistance in type 1 diabetes subjects. The plasma insulin concentration is acutely raised and maintained at 100 μU/ml by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.
These data will be compared with the results of a 13C glucose breath test. Breath tests using 13C substrates are based on the principle that 13C CO2 in the exhaled breath can be measured as a metabolic tracer.
Breath testing has a major advantage over the clamp test in that it can be performed non-invasively and repeatedly without necessary supervision by medical staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFLD+T1DM+ | Subjects with type 1 diabetes and ultrasound-defined NAFLD |
| |
| NAFLD-T1DM+ | Subjects with type 1 diabetes without ultrasound-defined NAFLD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| euglycaemic clamp test | Diagnostic Test | clamp test (golden standard) to determine insulin resistance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the 13C breath test with the golden standard | sensitivity and specificity analysis using linear regression | one day |
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Inclusion Criteria:
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Type 1 diabetes subjects from the research facility's outpatient clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Mertens, M.D. | Contact | +32 821 74 03 | jonathan.mertens@uza.be | |
| Maria Braspenning, nurse | Contact | +32 821 40 02 | Rie.Braspenning@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Christophe De Block, Prof. | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Recruiting | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24116833 | Background | Hussain M, Jangorbhani M, Schuette S, Considine RV, Chisholm RL, Mather KJ. [13C]glucose breath testing provides a noninvasive measure of insulin resistance: calibration analyses against clamp studies. Diabetes Technol Ther. 2014 Feb;16(2):102-12. doi: 10.1089/dia.2013.0151. Epub 2013 Oct 11. | |
| 27354200 | Background |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 13C glucose breath test | Diagnostic Test | 13C glucose breath test to compare with the golden standard |
|
| Maldonado-Hernandez J, Martinez-Basila A, Salas-Fernandez A, Navarro-Betancourt JR, Pina-Aguero MI, Bernabe-Garcia M. The 13C-Glucose Breath Test for Insulin Resistance Assessment in Adolescents: Comparison with Fasting and Post-Glucose Stimulus Surrogate Markers of Insulin Resistance. J Clin Res Pediatr Endocrinol. 2016 Dec 1;8(4):419-424. doi: 10.4274/jcrpe.3260. Epub 2016 Jun 29. |
| 14747226 | Result | Lewanczuk RZ, Paty BW, Toth EL. Comparison of the [13C]glucose breath test to the hyperinsulinemic-euglycemic clamp when determining insulin resistance. Diabetes Care. 2004 Feb;27(2):441-7. doi: 10.2337/diacare.27.2.441. |
| 38487831 | Derived | Mertens J, Roosens L, Braspenning R, Vandebeeck J, Francque S, De Block C. The 13C Glucose Breath Test Accurately Identifies Insulin Resistance in People With Type 1 Diabetes. J Clin Endocrinol Metab. 2025 Jan 21;110(2):e432-e442. doi: 10.1210/clinem/dgae175. |
| 38198792 | Derived | Clinck I, Mertens J, Wouters K, Dirinck E, De Block C. Insulin Resistance and CGM-Derived Parameters in People With Type 1 Diabetes: Are They Associated? J Clin Endocrinol Metab. 2024 Oct 15;109(11):e2131-e2140. doi: 10.1210/clinem/dgae015. |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |